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CTRI Number  CTRI/2022/04/042062 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 21/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   compare the effect of proprioceptive neuromuscular facilitation neck pattern and weight shift training on trunk control to improve balance in acute and sub-acute stroke patients-a randomized clinical trial 
Scientific Title of Study   effectiveness of proprioceptive neuromuscular facilitation neck pattern exercise versus weight shift training on trunk control to improve balance in acute and subacute stroke patients-a randomized clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PATEL NEHABEN RAJUBHAI 
Designation  MASTER OF PHYSIOTHERAPY STUDENT 
Affiliation  C. M. Patel College of Physiotherapy 
Address  Department of Neuro C M Patel College of Physiotherapy Civil Campus Sector 12 Gandhinagar
Department of Neuro C M Patel College of Physiotherapy Civil Campus Sector 12 Gandhinagar
Gandhinagar
GUJARAT
382016
India 
Phone  9687469092  
Fax    
Email  nehapatel4667@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rainy Bhuyan Sule 
Designation  Lecturer 
Affiliation  C. M. Patel College of Physiotherapy 
Address  Department of Neuro C M Patel College of Physiotherapy Civil Campus Sector 12 Gandhinagar
Department of Neuro C M Patel College of Physiotherapy Civil Campus Sector 12 Gandhinagar
Gandhinagar
GUJARAT
382016
India 
Phone  9712473750  
Fax    
Email  rainybhuyansule@gmail.com  
 
Details of Contact Person
Public Query  
Name  PATEL NEHABEN RAJUBHAI 
Designation  MASTER OF PHYSIOTHERAPY STUDENT 
Affiliation  C. M. Patel College of Physiotherapy 
Address  Department of Neuro C M Patel College of Physiotherapy Civil Campus Sector 12 Gandhinagar
Department of Neuro C M Patel College of Physiotherapy Civil Campus Sector 12 Gandhinagar
Gandhinagar
GUJARAT
382016
India 
Phone  9687469092  
Fax    
Email  nehapatel4667@gmail.com  
 
Source of Monetary or Material Support  
C M Patel College of Physiotherapy 
 
Primary Sponsor  
Name  C M Patel College of Physiotherpy 
Address  Civil Campus, Sector 12, Gandhinagar 
Type of Sponsor  Other [(Private Physiotherapy College)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neha Patel  DEPARTMENT OF NEURO, C M PATEL COLLEGE OF PHYSIOTHERAPY  CIVIL CAMPUS SECTOR 12 GANDHINAGAR GUJARAT
Gandhinagar
GUJARAT 		 9687469092

nehapatel4667@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, C. M. Patel College of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G89-G99||Other disorders of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PNF Neck Pattern  The proprioceptive Neuromuscular facilitation for neck pattern, both for 15 minutes. a) Neck flexion pattern b) Neck extension pattern a) Neck flexion pattern • Patient will be seated on a mat of knee height and hands placed on knee. • The therapist will stand behind the patient’s right side. • Put the right finger below the chin of the patient and left hand on the left top of the head diagonally. • The therapist pulls the patients chin lifted and extended thus the neck will be tilted and rotated towards the right side. • The patient will then asked to “pull his chin in and look at his left hip”. • The therapist will be given resistance against left flexion, left rotation and lateral flexion by providing traction to the chin. b) Neck extension pattern • Patient will instruct to follow the same procedure as before and the therapist will stand behind the patient’s right side. • The therapist will put his right thumb on the right side of the patients chin and places his left hand slightly at the right top of the patients head in a diagonal direction. • The patient assumes the preparation position in which the chin will pull, the neck will be flexed, and the head will be rotated and will tilt to the left. • The therapist will be instructed the patient to “lift your chin” and then “lift your head to look above”. • The patients head, Neck, and upper thoracic spine will have complete extension, right rotation, and right lateral flexion. • Resistance will be given by the therapist against right rotation, extension and lateral flexion during the exercise in order to induce strong muscle contractions.  
Comparator Agent  WEIGHT SHIFT TRAINING  Subjects will be instructed to sit with their arms folded and to shift their weights from midline to the right and left, as far as they can. The WST group will perform in four conditions. 1. First weight shift condition, subjects will instruct to sit on an exercise mat with legs extended, and have a balance pad under their buttocks. 2. Second weight-shift condition, subject will to sit with legs extended, have a balance pad under the buttocks, and a balance cushion under both heels. 3. The third weight shift condition, subjects will to sit on the edge of a testing table with a balance pad under the buttocks. 4. The fourth weight shift condition, to sit on the edge of a testing table, have a balance pad under the buttocks, and a balance cushion under the feet. Each position hold for 10 sec, 3 sets of 10 trials, 30 second break should be allowed between each set and 1 min break between each type of training. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed with stroke ( hemorrhagic or ischemic ) confirmed by CT/MRI.
Illness duration below 6 months.
Able to understand and follow the simple verbal instructions.
MMT score of trunk muscles more than 2, ability to sit independently on stable surface.
Muscle tone score of 2 or lower in affected lower extremity (modified ashworth scale).
Both male and female included.
Age group 50-80 years. 
 
ExclusionCriteria 
Details  High-risk heart disease
Had undergone any fracture or orthopedic surgeries (cervical or trunk region).
Recurrent stroke
Spinal deformities like kyphosis, scoliosis and lordosis.
Chronic Neck pain or back pain.
Psychosocial disorders like depression, anxiety.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Trunk impairment scale
 		 baseline to 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
berg balance scale  baseline to 6th week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Stroke is second leading cause of death and the third leading cause of disability. Due to the sudden death of brain cells by lacking of oxygen, when blood flow to the brain is lost by blockage or rupture of an artery. 85.5% of stroke patients are living with disabilities. The definition for stroke by world health organization (WHO) is “Rapidly developed clinical signs of focal disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than vascular origin”. • Trunk performance has been identified as an important independent predictor of ADL after stroke.The trunk muscle weakness and the loss of proprioception concerning the affected side can interfere with balance, stability, and functional disability. Trunk control is the ability to maintain the upright posture, to adjust weight shifting, and to perform selective movements in the trunk to maintain the center of mass within the base of support. Trunk movements are necessary to maintain postural control, and the function of trunk muscles is an essential factor for balance, transfers, gait, and the range of activities in daily living.• Proprioceptive Neuromuscular Facilitation (PNF) is a rehabilitation technique, which is widely used by physiotherapists and forms part of physiotherapy.  PNF uses the body’s proprioceptive system to facilitate or inhibit muscle contraction. Proprioceptive neuromuscular facilitation is a dynamic approach to the evaluation and treatment of neuromuscular dysfunction on the trunk. The resistance against the neck exercise causes irradiation in the body-trunk muscle exercise. However, few studies have investigated the improvement in trunk control in chronic stroke patients as a result of using the PNF neck pattern. • Weight shifting and balance are fundamental functional activities. Weight shifting training perform on unstable surface in sitting that may improve trunk control and dynamic balance in chronic stroke patients. • The Trunk Impairment Scale(TIS) consists of three subscales: static sitting balance, dynamic sitting balance and co-ordination. Each subscale contains between three and ten items. The TIS score ranges from a minimum of 0 to a maximum of 23. A study demonstrate that the dynamic sitting balance and coordination subscale are valid measures of selective trunk performance in people after stroke and can be utilized with confidence in clinical practice and stroke rehabilitation research. The Berg Balance Scale(BBS) measures multi-tasking ability and includes 14 items that require participants to maintain their balance in different tasks and positions with various levels of difficulty. Each item is scored from 0 to 4 points, total score is 56.The strong psychometric properties of the BBS demonstrated by this systematic review suggest that it is an effective and appropriate assessment of balance in patients with stroke.
Impaired trunk stability and imbalance has been proved to be the cause of limitation in daily living activities in patients suffering from stroke. There are many studies available on the fact that trunk specific exercises and the proprioceptive neuromuscular facilitation trunk pattern would improve in patients with stroke. However, no available study for comparison of the proprioceptive neuromuscular facilitation neck pattern and weight shift training for improvement of trunk control. Thus, focus of the present study is to prove the effectiveness of both proprioceptive neuromuscular facilitation neck pattern and weight shift training program individually as well as in comparison on trunk improvement in acute and subacute stroke patients.

 
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